MHRA: MHRA announces an exercise to update Summaries of Product Characteristics (SmPCs) to include paediatric information following completion of European work-sharing procedures

Inclusion of paediatric information in marketing authorisations following european work-sharing procedures ...

EMEA: Paediatric investigation plans (PIPs), waivers and modifications - Procedural Advice

This procedural advice addresses a number of questions which applicants may have before submitting an application. The information provided - under the form of Questions and Answers - will be ...

FDA: Providing Regulatory Submissions in Electronic Format--Drug Establishment Registration and Drug Listing

This guidance document is designed to assist industry (e.g., manufacturers, repackers, and relabelers) with the electronic submission of drug establishment registration and drug listing ...

FDA: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis Small Entity Compliance Guide

On September 29, 2008, FDA published in the Federal Register a final rule (73 FR 56477, corrected at 73 FR 66754, November 12, 2008) that amended its regulations on the calcium and osteoporosis ...

European Commision: Pharmaceutical legislation aligned with the new regulatory procedure with scrutiny

Regulation (EC) No 219/2009 of the European Parliament and of the Council of 11 March 2009 adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to ...

EMEA: Rules for the implementation of Regulation (EC) No 297/95 as amended on fees payable to the European Medicines Agency and other measures

The rules apply to: Scientific advice and protocol assistance Scientific services Extension of marketing authorisations Type II variations Annual fee Administration ...

EMEA: Revised Distribution Requirements and Address Lists for Periodic Safety Update Reports (PSURs)

Annex 6.2 of Volume 9A of the Rules Governing Medicinal Products in the EU ...

FDA: Presenting Risk Information in Prescription Drug and Medical Device Promotion

This guidance responds to stakeholder requests for specific guidance on how FDA evaluates prescription drug and medical device promotional pieces to determine whether they adequately present risk ...

EMEA: Guideline on the Clinical Investigation of Medicinal Products for the Treatment of Ankylosing Spondylitis

This Guideline is intended to provide guidance for the clinical evaluation of new medicinal products for the treatment of ankylosing spondylitis (AS), a chronic inflammatory disease that affects ...

EMEA: Guideline on the Clinical evaluation of direct acting antiviral agents intended for treatment of chronic hepatitis C

The aim of this guideline is to provide guidance on the clinical development of compounds for the treatment of Chronic Hepatitis C (CHC). It should be read in conjunction with updated and ...

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